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    List of Drug Master Files (KDMF) for Pibrentasvir Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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    Pibrentasvir

    APIs // Active Pharmaceutical Ingredients

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    01 [Raw drug product manufacturing] Abbvie Ireland NL BV@[Intermediate 1-5 manufacturing] Procos SpA (1)

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    01 AbbVie Korea Co., Ltd. (2)

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    01 pibrentasvir (2)

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    AbbVie Inc

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    pibrentasvir

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    AbbVie Korea Co., Ltd.
    2017-12-15
    Number 325-8-ND
    [Raw drug product manufac...
    U.S.A
    Manorhamilton Road, Sligo...
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    ACS DOBFAR SPA

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    pibrentasvir

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    AbbVie Korea Co., Ltd.
    2020-10-08
    Wed325-13-ND
    AbbVie Srl
    Italy
    SR 148 Pontina km 52, Snc...
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    Looking for 1353900-92-1 / Pibrentasvir API manufacturers, exporters & distributors?

    Pibrentasvir manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Pibrentasvir API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Pibrentasvir manufacturer or Pibrentasvir supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pibrentasvir manufacturer or Pibrentasvir supplier.

    PharmaCompass also assists you with knowing the Pibrentasvir API Price utilized in the formulation of products. Pibrentasvir API Price is not always fixed or binding as the Pibrentasvir Price is obtained through a variety of data sources. The Pibrentasvir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Pibrentasvir

    Synonyms

    1353900-92-1, Abt-530, Pibrentasvir [usan], Abt 530, A-1325912.0, Abt530

    Cas Number

    1353900-92-1

    Unique Ingredient Identifier (UNII)

    2WU922TK3L

    About Pibrentasvir

    Pibrentasvir is a direct acting antiviral agent and Hepatitis C virus (HCV) NS5A inhibitor that targets the the viral RNA replication and viron assembly. In combination with [DB13879], pibrentastiv is a useful therapy for patients who experienced therapeutic failure from other NS5A inhibitors. In cell cultures, the emergence of amino acid substitutions at known NS5A inhibitor resistance-associated positions in HCV genotype 1a, 2a or 3a replicons led to reduced susceptibility and resistance to pibrentasvir. These resistance-associated amino acid substitutions included Q30D/deletion, Y93D/H/N or H58D +Y93H in genotype 1a replicons, F28S + M31I or P29S + K30G in genotype 2a replicons, and Y93H in genotype 3a replicons. Individual NS5A amino acid substitutions that reduced susceptibility to pibrentasvir include M28G or Q30D in a genotype 1a replicon and P32-deletion in a genotype 1b replicon. Pibrentasvir is available as an oral combination therapy with [DB13879] under the brand name Mavyret. This fixed-dose combination therapy was FDA-approved in August 2017 to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also indicated for HCV genotype 1-infected patients who have been previously treated with regimens either containing an NS5A inhibitor or an NS3/4A protease inhibitor, but not both. Hepatitis C viral infection often leads to decreased liver function and subsequent liver failure, causing a significantly negative impact on the patients' quality of life. The ultimate goal of the combination treatment is to achieve sustained virologic response (SVR) and cure the patients from the infection. In clinical trials, this combination therapy achieved SVR12 rate, or undetectable Hepatitis C for twelve or more weeks after the end of treatment, of 93% across genotypes 1a, 2a, 3a, 4, 5 and 6.

    Pibrentasvir Manufacturers

    A Pibrentasvir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pibrentasvir, including repackagers and relabelers. The FDA regulates Pibrentasvir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pibrentasvir API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Pibrentasvir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Pibrentasvir Suppliers

    A Pibrentasvir supplier is an individual or a company that provides Pibrentasvir active pharmaceutical ingredient (API) or Pibrentasvir finished formulations upon request. The Pibrentasvir suppliers may include Pibrentasvir API manufacturers, exporters, distributors and traders.

    click here to find a list of Pibrentasvir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Pibrentasvir KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Pibrentasvir Drug Master File in Korea (Pibrentasvir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pibrentasvir. The MFDS reviews the Pibrentasvir KDMF as part of the drug registration process and uses the information provided in the Pibrentasvir KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Pibrentasvir KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Pibrentasvir API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Pibrentasvir suppliers with KDMF on PharmaCompass.

    Pibrentasvir Manufacturers | Traders | Suppliers

    Pibrentasvir Manufacturers, Traders, Suppliers 1
    85

    We have 2 companies offering Pibrentasvir

    Get in contact with the supplier of your choice:

    1. AbbVie Inc
    2. ACS DOBFAR SPA
    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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